Medicament package and process



1934- P. a. HEINEMAN MEDICAMENT PACKAGE AND PROCESS Original Fild Sept. 26 1927 INVENLI'OR @atentecl c in y 24%, E934 STATES PATENT OFFICE Laboratories, Inc., Chicago, 111.,

o! Delaware Application September 26, 1927, Serial No. 222,150 E Renewed December I, 1933 a corporation 6 Claims- (CL 128-218) This invention relates to medicament packages, and processes of preparing the same for use; and among other objects aims to provide a sealed, aseptic medicament container so constructed and arranged that it may be used to carry a concentrated but unstable medicament which by the improved process is diluted, without contaminatio immediately before use. The

invention is particularly useful in the preparation of medicaments for hypodermic injections, for example, the medicament used in the Schick test for immunity from diphtheria. This medicament is in liquid form. The new package, however, is not only useful for medicaments in 1! liquid, but also for such in solid form. As examples, a Novocain bufier mixture, or Neoarsphenamine, or the alkali salts of barbituric acids, in general, solid substances which in aqueous solutions are stable only for a short period of time, may be mentioned.

In the accompanyi drawing showing two embodiments of the improved package, and also instrumentalities by which the process may be carried out,-

Fig. 1 is an elevation of a medicament container embodying the invention;

Fig. 2 is a similar view of a slightly modified form, with parts of thewall broken away;

Fig. 3 is an enlarged longitudinal section of the form of invention shown in Fig. l; and

Fig. 4 is a sectional view on the scale of Fig. 1 showing the preferred means by which the process is practiced. l

Referring more specifically to the drawing,

3 there is shown in Figs.

container comprising abody 5 formed, for example, from a section of a glass tube sealed near one end by a slidable rubber plug 6 and at the other end by, a wad of cotton wool 7. The embodiment-of the invention illustrated in 2 difiers only'in the substitution'of a slidable rub-- ber plu allikeplugvfi) for the wad of cotton r1001 '1. The-containers of Figs. 2 and 3 are both empty between the slidable plug 6 and the closure 7' .or 8, except for sterile However, adjacent to-the plug 6 is another, rubber plug 9 whichis inserted in the endof-tube 5 and which has a, -cavity 10 opening-. interi orly and containing a small quantity of concentrated medicament of acharacter'which, if diluted, would be unstable and hence make the package unmarketable.

Itwillbe clear fromFig. 3 that the'plug 6, in conjunction with the cavity 10 in plug 9, provides a sealed chamber of small capacity, whose 1 and 3 a medicamentstep. centrated medicaments been effected by -ing agent, whose volume walls are wholly of rubber thus preserving the concentrated medicament out of contact with the glass walls of the tube 5. The described medicament package may be prepared by inserting the rubber plugs 6 and 9 into one end of the cleansed tube 5, the plug 6 preceding the plug 9, and then sterilizing the tube containing the two plugs. Immediately after sterilization, the wad of cotton wool '1 (or another plug closure 8) is inserted into the other end of the tube so as to obviate the possi-- bility of contamination entering through that end. A second sterilization may then be resorted to. The empty packages may beimmediately filled or may be stored until filling is convenient, without the possibility of contamination entering the space between the plugs 6 and '1 or the closed chamber 10 provided by the abuttedplugs 6, 9.

When it is desired to fill the chamber 10, a thin filling needle (not shown) having two bores, one connected with a source of vacuum and the other with a supply of medicament, may be thrust axially through the body of the plug 9, the end of such needle penetrating only as far as the cavity and being withheld from entering the plug 6 which would seat it. The plug 9, as shown, is mechanically interlocked with the end of the tube 5, for example, by means of a flange 11 .which fits against the end of the tube, preventing'inward movement of the plug 9 when pierced by the filling instrumentality. As soon as the end of the filling needle enters the cavity 10, the air in the cavity will be exhausted and the cavity will be filled with the concentrated 90 medicamentwhich it is desired to preserve in the package. The packages may now be prepared for the *marketand may be stored for considerable periods of time without deterioration of their contents. methods may be employed. I

In order to prepare the package for use, its contents must be diluted with or dissolved by a medicament of predetermined volume, whose sterility must not be by the diluting 100 Accordingto old practice, dilution of conpouring such medicaments into open vessels (which are exposed to the atmosphere and all that it contains) and then in the'dilut has been measured more or less imperfectly by the practitioner. Then the solution thus prepared is usually boiled to sterilize it, and is then poured into a syringe I0! hypodermic or other administration. Such 110 Obviously, other filling methods are 'unsaie because of the possibility of contamination even after boiling, not only from the impurities present in the atmosphere itself but also from the syringe and from the handling or close contact of the practitioner. Furthermore, the boiling after mixing inevitably reduces the volume of the medicament andthere is always some loss due to evaporation and incident upon pouring and repouring from one vessel to another. Thus there is waste of the medicament to be administered and there is an inevitable variation in its concentration andvolume, as well as loss of time which may be most valuable to the practitioner. -Moreover'," in some instances, boiling cannot be resorted to because this would decompose the medicament to be administered. The above procedure and others known to the medical and dental professions are eliminated by the improved process hereinafter described and claimed.

- Referring to Fig. 4i there is shown a syringe 12 carrying a medicament package 13 which contains a diluting agent especially prepared for diluting the particular concentrated medicament in the package' 5. The syringe 12 includes a slidable plunger 14 which engages the slidable plug 15 of the medicament package 13, the other end of the package being closed by a plug 16 constructed like the plug 9 of the package shown i in Fig. 3 and being piercedby a hollow doublepointed needle 17 carried by the forward end of the syringe. l

In order to transfer the contents of package 13 to the interior of package 5 without contamination or loss, it is only necessary to introduce the end of the needle 17 into the cavity 10.by piercing the wall of the plug 9 axially, as shown in the drawing and then to push the plunger 14 inwardly. This slides the plug 15 toward the forward end of the syringe 12 causing the medicament to flow through the bore of needle 17 into the space between plugs 6 and 9.- As plug 9 is not movable, while plug 6 is readily slidable, the latter slides outwardly at the same rate as plug 15 is moved by the plunger 14-. The sterile air in the container 5 between plugs 6 and 7 is pushed out past the cotton plug 7 and through the intersticesthereof. If the transfer is made rapidly, the air might become compressed somewhat, in which event it will blow out the plug 7 (or the plug 8, as the case may be); but the plug 6 immediately closes the tube 5 because it is' moved to the end of the tubeas fast as the plug 15 is moved toward plug 16. It will be noted that as the plug 6 hermetically. seals the container, no'air which may'momentarily enter the container'when the sealing plug 7, 8 is blown out, can contaminate the diluted medicament in the package 5.

'It will be clear that the plugs 6 and 9 need not be abutted'against each other if the medicament to be packaged isstable in contact with glass, and if it is of such volume as to exceed the capacity of the cavity provided by plug 9. Furthermore, it will be evident that no airfcan enter the space between the plugs 6 and 9, if the piercing operation is performed properly.-- Once the concentrated medicament .is diluted or dissolved, the package 5 may be immediately used for an injection, or series of injections.

Obviously the invention may be embodied in packages having other forms than the twoshown; and the process may be carried out by means-of other apparatus than the illustrativeinstrument described above.

memes What I claim is:-

1. An aseptic package for concentrated medicaments which is particularly adapted to facilitate dilution of the contents thereof without contact with the air, comprising, in combination, a glass tube; a resilientplug inserted in the tube at ,one endand having a cavityopening interiorly and. being constructed and arranged so that inward movement thereof through the ,tube is prevented; and another resilient plug adjacent the plug having the cavity and so constructediandarranged that it forms a closed, sterile chamber, Within the tube, in conjunction 'with thefother plug; said abutted plug being tween the pierceable plug andthe slidable plug. a

which may contain a small volume of concentrated medicament.

' 3. A medicament package comprising, in combination, a rigid tube open atboth ends; a pierceable resilient plug sealing one end; and-a resilient, slidable plugadjacent the pierceable plugand movable by hydrostatic pressure through the tube to the'other end; there'being a small chamberconflned between the pierceable plug .and the slidable plug which contains a small volume of concentrated medicament.

- 4. A processofipreparing for immediate use medicament packages containing concentratedmedicament which must be diluted or dissolved before use, comprising piercing. a 'wall of the package containing 'the concentrated medica-- ment with a piercing medium of small diameter, andpreventing the entrance of airtherein; and employing hydrostatic pressure. created .within another package-containing the solvent or-diluting agent to transfer the solvent or diluting agent directly. into the package containing the concentratedmedicament without contact with the air,- and alsoto push back a wall-of said package -to :expand its :.volume sufllciently to contain the diluted or dissolved medicament. a

5. A process of preparing packages of medicasageway therein withtwo substantiallyjuxtagposed plugs closing one end; the plugs being so arranged that a-sealed' spa'celof-small volumeis provided between them" and being relatively movable; then: injecting into said space medicament which must 'beudiluted .before' use, which is sufliciently. concentrated to be relatively-i quite stable; and;then',-=just before medicament is to be-used, injecting into said space, under .pressurafla' solvent-' or diluting" agent sufllcient 'in volume toxmake a correct solution :after it has mixed with the concerttrated medicament; the injection'under ofthe diluting agent separating the two ini-- tially'juxtaposed plugs to provide a sealed chamher for the diluted or dissolved medicament, 'thus' obviating contact of the medicament. with-the" atmosphere-either during or afterfthe dilution or 1,

' 6. A process of preparing packages" of age, said solvent or diluting agent being coned between two resilient closures, one of which is slidable end to end. of the package; piercing the two closures of respective packages, which closures are designed not to be moverl, by means of a canula; and transferring the solvent or diluting agent from the second package to the first through said camila, the discharge end of which is initially placed within time space between the two juxtaposed plugs of the first package.

G. RENEE/LAN.

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